The objectives of the randomized, double-blinded,
multiple-crossover Phase 2 trial were to assess the safety and
efficacy of Tolenix™ in reducing the frequency of
micturition (urination) and incontinence episodes per day, as
compared to both placebo control and active control
Detrol® (tolterodine tartrate). In addition,
common side effects of muscarinic antagonist therapies, such as dry
mouth, were carefully assessed in the 138 patients enrolled in the
trial. This international Phase 2 clinical trial was
conducted in South Korea,
Australia, and New Zealand.

Patients receiving Tolenix™ (2mg
tolterodine plus 9mg pilocarpine, administered BID) experienced
statistically significant improvements in their OAB and UUI
symptoms over placebo control, as well as efficacy similar in
magnitude to the maximum dose of active control
Detrol® (2mg tolterodine, administered BID).
Patients receiving Tolenix™ exhibited no
significant safety issues, and demonstrated statistically
significant and clinically meaningful improvements in their saliva
production and dry mouth side effects, as compared to active
control Detrol®. TheraVida intends to present
detailed efficacy and tolerability results from the Phase 2 trial
of Tolenix™ at an upcoming scientific meeting.

"Results from this Phase 2 clinical trial clearly
demonstrate that Tolenix™ has the ability to
provide patients with bladder control, while reducing dry mouth
side effects typically associated with OAB medications such as
Detrol®," said Roger Flugel, Ph.D., Chief Executive
Officer at TheraVida. "Dry mouth side effects are a primary
reason why patients stop taking medicines to treat their OAB and
urgency-related micturition symptoms. We believe there is a
significant opportunity for a new OAB treatment option for
currently diagnosed patients and the aging population.
Tolenix™ has the potential to improve the overall
tolerability, compliance, and satisfaction for patients with OAB
and UUI."

This Phase 2 study also demonstrated a favorable
therapeutic index, which may enable higher dosing of
Tolenix™ in some patients. A higher dose of
Tolenix™ (3mg tolterodine plus 13.5mg pilocarpine,
administered BID) was studied in a 12-week open-label extension
period, in a subset of patients in this Phase 2 trial. In
this extension period, the higher dose of Tolenix™
exhibited the potential to provide greater bladder control, while
minimizing dry mouth side effects.

TheraVida intends to conduct additional international
clinical trials of Tolenix™ in patients with OAB
and UUI.

About Overactive Bladder (OAB)OAB is
primarily a disease of aging, characterized by an increase in
urinary frequency, urinary incontinence and nocturia (waking at
night to urinate). OAB is a common disorder, affecting
approximately 16% to 17% of the population worldwide, with a
prevalence similar to diabetes or asthma. As the world
population continues to age, the prevalence of OAB is expected to
increase.

About Tolenix™(THVD-201)Tolenix™ is a novel,
patent-protected therapeutic that combines the muscarinic
antagonist tolterodine with a modified-release formulation of the
muscarinic agonist (salivary stimulant) pilocarpine.
Tolenix™ incorporates a unique and
proprietary combination drug technology developed by TheraVida that
can be applied to any of the standard muscarinic antagonist
therapies used to treat OAB, to overcome problematic dry mouth
typically associated with this class of pharmacological agents.
TheraVida combination drug products such as
Tolenix™ have the potential for greater efficacy,
improved tolerability, and better patient compliance, when compared
to tolterodine alone for the treatment of OAB and UUI.

About TheraVidaTheraVida, Inc., is
applying its unique and patent-protected combination drug
technology to develop products that offer patients therapeutic
benefits with significantly better side effect, safety, and
efficacy profiles when compared with predecessor, standard-of-care
therapies. The company's lead product,
Tolenix™ (THVD-201) is being developed for the
treatment of overactive bladder (OAB) and urge urinary incontinence
(UUI) and is advancing into Phase 3 clinical studies. For
further information, please visit www.theravida.com.